DICLOFENAC SODIUM tablet, delayed release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)

Prieinama:

STAT Rx USA LLC

INN (Tarptautinis Pavadinimas):

DICLOFENAC SODIUM

Sudėtis:

DICLOFENAC SODIUM 50 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium delayed-release tablets are indicated: - For relief of the signs and symptoms of osteoarthritis - For relief of the signs and symptoms of rheumatoid arthritis - For acute and long-term use in the relief of signs and symptoms of ankylosing aponsylitis. Diclofenac sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac should not be given to patients who have experienced asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactoid Reactions and PRECAUTIONS: Preexisting Asthma

Produkto santrauka:

Diclofenac Sodium Delayed-release Tablets, USP are available containing 50 mg or 75 mg of diclofenac sodium, USP. The 50 mg tablet is a light brown round, unscored, enteric coated tablet imprinted with G-DS-50 in black ink. They are available as follows: NDC 42549-589-30 bottles of 30 NDC 42549-589-60 bottles of 60 NDC 42549-589-90 bottles of 90 The 75 mg tablet is a light pink round, unscored, enteric coated tablet imprinted with G-DS-75 in black ink. They are available as follows: NDC 42549-510-30 bottles of 30 NDC 42549-510-60 bottles of 60 NDC 42549-510-90 bottles of 90 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as described in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. Manufactured in Australia by: ALPHAPHARM PTY. LTD. 15 Garnet St. Carole Park QLD 4300 Australia ALP:DICLDR:R1mc Relabeling and Repackaging by : STAT Rx USA LLC Gainesville, GA  30501

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

STAT Rx USA LLC
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MEDICATION GUIDE FOR NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This chance
increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a “coronary artery
bypass graft (CABG).”
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called “corticosteroids” and “anticoagulants”
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines are used to treat pain and redness, swelling, and heat
(inflammation) from medical
conditions such as:
•
different types of arthritis
•
menstrual cramps and other types of short-term pain
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and pharmacist.
•
if you are pregnant. NSAID medicines should

Prekės savybės

DICLOFENAC SODIUM - DICLOFENAC SODIUM TABLET, DELAYED RELEASE
STAT RX USA LLC
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DICLOFENAC SOD DR
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction and stroke, which can be fatal. This risk may increase with
duration of use. Patients
with cardiovascular disease or risk factors for cardiovascular disease
may be at greater risk
(see WARNINGS).
Diclofenac is contraindicated for the treatment of perioperative pain
in the setting of coronary
artery bypass graft (CABG) surgery (see WARNINGS).
GASTROINTESTINAL RISK
NSAIDs cause an increased risk of serious gastrointestinal adverse
events including
inflammation, bleeding, ulceration and perforation of the stomach or
intestines, which can be
fatal. These events can occur at any time during use and without
warning symptoms. Elderly
patients are at greater risk for serious gastrointestinal events (see
WARNINGS).
DESCRIPTION
Diclofenac, as the sodium salt, is a benzene-acetic acid derivative,
designated chemically as Sodium [_o_-
(2,6-dichloroanilino)phenyl]acetate. The molecular weight is 318.13.
Its molecular formula is
C
H Cl
NNaO and it has the following structural formula:
Diclofenac sodium USP, is a faintly yellowish white to light beige,
virtually odorless, slightly
hygroscopic crystalline powder. The molecular weight of the sodium
salt is 318.13. It is freely soluble
in methanol, soluble in ethanol, and practically insoluble in
chloroform and in dilute acid. Diclofenac
sodium is sparingly soluble in water. The n-octanol/water partition
coefficient is 13.4 at pH 7.4 and
1545 at pH 5.2. The sodium salt has a single dissociation constant
(pKa) of 4.0 ± 0.2 at 25ºC in water.
Each delayed-release tablet for oral administration contains 50 mg or
75 mg of diclofenac sodium. In
addition, each tablet contains the following inactive ingredients:
crospovidone, FD & C Blue No. 2
Aluminum Lake (50 mg), FD & C Red No. 40 (75 mg), FD & C Yellow No. 6,
hypromellose, iron oxide
yellow (50 mg), lactose